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510(k) Data Aggregation
K Number
K060064Device Name
STETHOFLUX
Manufacturer
ODVI
Date Cleared
2006-04-10
(91 days)
Product Code
JAF
Regulation Number
892.1540Why did this record match?
Applicant Name (Manufacturer) :
ODVI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic ultrasound blood flow detection of the human body. The Stethoflux is designed for use by general practitioners or specialists on their own responsibility. It allows dual stethoscopic and doppler peripheral vascular investigation in a simple auscultation. It facilitates: - the detection of blood-flow in the peripheral arteries - Systolic Blood Pressures (SBP) measurements of the lower limb and upper-limb in order to determine the possible PAD ankle Brachial index (ABI) in the concerned limb. when associated with a sphygmomanometer
Device Description
Acoustic stethoscope with ultrasonic transducer. It operates with 2 modes stethoscopic mode (classical stethoscope) and Doppler mode. Powered by one (6LR61) 9V lenium battery. Doppler frequency: 8 MHz. Operating time 25 h according to use. Mass 331 g.
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